NCT07327060

Brief Summary

The aim of this randomized controlled trial is to test the null hypothesis that parent education using an intraoral camera has no effect on children's oral hygiene levels, parental oral health literacy, or plaque accumulation on first permanent molars compared with standard verbal education. 40 children aged 5-7 and their parents will be randomly assigned to two groups. The intervention group will receive real-time visualization of dental conditions and brushing techniques using an intraoral camera, while the control group will receive standard verbal education using a brushing model. Outcomes include children's plaque and gum health and ICDAS caries scores. Secondary outcomes include Occlusal Plaque Index (OPI) on first molars. Assessments will be conducted at baseline and 1-month follow-up. This study tests whether intraoral camera-assisted education leads to better oral hygiene outcomes in children, improves parents' oral health literacy, and reduces plaque accumulation on the first permanent molars compared to standard verbal education.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 9, 2026

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

December 25, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

Oral health literacyOral Health Careİntraoral camera

Outcome Measures

Primary Outcomes (8)

  • Children's Plaque Index (PI)

    Plaque levels on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, were assessed using the Silness and Löe Plaque Index (scores 0-3). Plaque Index and Criteria: 0.Absence of microbial plaque 1. Thin film of microbial plaque along the free gingival margin 2. Moderate accumulation with plaque in the sulcus 3. Large amount of plaque in sulcus or pocket along the free gingival margin

    Baseline

  • Children's Plaque Index (PI)

    Plaque levels on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, were assessed using the Silness and Löe Plaque Index (scores 0-3). Plaque Index and Criteria: 0\. Absence of microbial plaque 1. Thin film of microbial plaque along the free gingival margin 2. Moderate accumulation with plaque in the sulcus 3. Large amount of plaque in sulcus or pocket along the free gingival margin

    1 month after intervention

  • Children's Gingival Index (GI)

    Gingival status was assessed on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, using the Löe and Silness Gingival Index (0-3). Gingival Index (GI) and Criteria: 0\. Normal gingiva; no inflammation; no discoloration (erythema); no bleeding. 1. Mild inflammation; slight erythema; minimal superficial alterations; no bleeding. 2. Moderate inflammation; erythema; bleeding on probing. 3. Severe inflammation; severe erythema and swelling; tendency to spontaneous bleeding; possible ulceration.

    Baseline

  • Children's Gingival Index (GI)

    Gingival status was assessed on the mesial, distal, buccal, and lingual surfaces of all present teeth, excluding partially erupted teeth, using the Löe and Silness Gingival Index (0-3). Gingival Index (GI) and Criteria: 0\. Normal gingiva; no inflammation; no discoloration (erythema); no bleeding. 1. Mild inflammation; slight erythema; minimal superficial alterations; no bleeding. 2. Moderate inflammation; erythema; bleeding on probing. 3. Severe inflammation; severe erythema and swelling; tendency to spontaneous bleeding; possible ulceration.

    1 month after intervention

  • ICDAS Caries Score

    Caries status of all present teeth, excluding partially erupted teeth, was recorded using the International Caries Detection and Assessment System (ICDAS). ICDAS Codes (International Caries Detection and Assessment System) 0\. Sound tooth surface 1. First visual change in enamel 2. Distinct visual change in enamel 3. Localized enamel breakdown due to caries with no visible dentin 4. Underlying dark shadow from dentin (with or without enamel breakdown) 5. Distinct cavity with visible dentin 6. Extensive distinct cavity with visible dentin

    Baseline

  • ICDAS Caries Score

    Caries status of all present teeth, excluding partially erupted teeth, was recorded using the International Caries Detection and Assessment System (ICDAS). ICDAS Codes (International Caries Detection and Assessment System) 0\. Sound tooth surface 1. First visual change in enamel 2. Distinct visual change in enamel 3. Localized enamel breakdown due to caries with no visible dentin 4. Underlying dark shadow from dentin (with or without enamel breakdown) 5. Distinct cavity with visible dentin 6. Extensive distinct cavity with visible dentin

    1 month after intervention

  • Parental Oral Health Literacy (TOHLAT-P)

    Parents' oral health literacy, understanding of preventive care, and ability to support children's oral hygiene, assessed by TOHLAT-P. This questionnaire is used to assess parents' oral health knowledge. It measures three types of knowledge (factual, procedural, and conceptual) and includes cognitive process levels (remembering, understanding, and analyzing). The tool also uses literacy and numeracy skills. It has three sections. The maximum score for each section is 12, 26, and 14. The total score range is 0-52. Higher scores indicate higher oral health literacy.

    Baseline

  • Parental Oral Health Literacy (TOHLAT-P)

    Parents' oral health literacy, understanding of preventive care, and ability to support children's oral hygiene, assessed by TOHLAT-P. This questionnaire is used to assess parents' oral health knowledge. It measures three types of knowledge (factual, procedural, and conceptual) and includes cognitive process levels (remembering, understanding, and analyzing). The tool also uses literacy and numeracy skills. It has three sections. The maximum score for each section is 12, 26, and 14. The total score range is 0-52. Higher scores indicate higher oral health literacy.

    1 month after intervention

Secondary Outcomes (3)

  • Occlusal Plaque Index (OPI)

    Baseline

  • Occlusal Plaque Index (OPI)

    1 month after intervention

  • Parent and Child Satisfaction with Intraoral Camera-Assisted Education

    At 1 month after intervention

Study Arms (2)

Intraoral Camera-Assisted Oral Hygiene Education

EXPERIMENTAL

In the intervention group, explanations provided during the oral examination will be visualized using an intraoral camera. After recording oral hygiene scores, a disclosing agent will be applied to the teeth. Following gentle rinsing and isolation, areas stained by plaque and not effectively cleaned will be highlighted, and brushing will be demonstrated accordingly. Using the Modified Stillman technique, the specific areas requiring toothbrush contact will be shown directly in the patient's mouth with intraoral camera visualization. Signs of gingival inflammation such as redness or swelling, as well as caries and plaque deposits, will also be displayed in real time. This approach individualizes the education, enabling both the child and parent to better understand and retain the oral hygiene instructions.

Behavioral: Intraoral Camera-Assisted Oral Hygiene EducationDevice: Intraoral Photography of Permanent First MolarsBehavioral: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P)Other: Parent and Child Satisfaction Survey

Standard Verbal Oral Hygiene Education

ACTIVE COMPARATOR

Children in the control group undergo oral examination at the dental unit using a mirror and probe. Standard verbal oral hygiene education is provided to children and parents, including information on dental plaque, oral hygiene importance, and treatment needs. Brushing is demonstrated on a model using the Modified Stillman technique to ensure effective plaque control without harming the gingiva. For partially erupted permanent first molars, the "cross brushing" technique with horizontal bucco-lingual movements is also explained.

Behavioral: Standard Verbal Oral Hygiene EducationDevice: Intraoral Photography of Permanent First MolarsBehavioral: Turkish Version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P)

Interventions

Participants receive individualized oral hygiene education using an intraoral camera. Dental findings such as plaque, caries, and gingival inflammation are visualized in real time. Disclosing agents highlight plaque-covered areas, and brushing demonstrations are performed directly on the child's teeth using the Modified Stillman and cross-brushing techniques. Parents and children receive visual feedback to reinforce proper oral hygiene practices.

Intraoral Camera-Assisted Oral Hygiene Education

Participants receive standard verbal oral hygiene education using a brushing model. The Modified Stillman and cross-brushing techniques are demonstrated verbally and on the model. Oral hygiene principles, plaque control, and the importance of regular brushing are explained to both children and parents.

Standard Verbal Oral Hygiene Education

Occlusal surfaces of permanent first molars will be photographed using the EZCAM VATECH intraoral camera to document plaque accumulation. The photographs will be shown only to participants in the camera-assisted education group during oral hygiene instruction. These images will help them see plaque areas and understand correct brushing. The control group will receive only verbal education and will not view the photographs. All images will be stored securely and used only for evaluation in the study.

Intraoral Camera-Assisted Oral Hygiene EducationStandard Verbal Oral Hygiene Education

A structured questionnaire was given to children and parents in the intraoral camera education group. The aim was to evaluate their satisfaction with the education process. The questionnaire focused on the usability of the intraoral camera and how helpful it was during dental education.

Intraoral Camera-Assisted Oral Hygiene Education

Parental oral health literacy, knowledge about preventive dental care, and their ability to help their child with oral hygiene will be measured using the Turkish version of the Oral Health Literacy Assessment Task for Pediatric Dentistry (TOHLAT-P). This tool evaluates parents' understanding and use of oral health information. Higher scores indicate better oral health literacy.

Intraoral Camera-Assisted Oral Hygiene EducationStandard Verbal Oral Hygiene Education

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Systemically healthy children
  • Age between 5-7 years, with at least one first permanent molar in the eruption stage
  • No urgent treatment needs (e.g., dental trauma or pain)
  • Voluntary participation with signed and verbal informed consent from parents, and willingness to attend follow-up visits regularly

You may not qualify if:

  • Children with special healthcare needs, intellectual disabilities, or autism spectrum disorder
  • Children with a Frankl Behavior Rating Scale score of 1 (Definitely negative)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Dentistry

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Related Publications (18)

  • Buldur B, Oguz E. Reliability and validity of the Turkish version of the Oral Health Literacy Assessment Task: Pathways between parental oral health literacy and oral health consequences in children. Int J Paediatr Dent. 2023 Mar;33(2):101-112. doi: 10.1111/ipd.13025. Epub 2022 Jul 26.

    PMID: 35851730BACKGROUND
  • Carvalho JC. Chapter 9.2: Non-Operative Treatment of Coronal Caries. Monogr Oral Sci. 2023;31:149-171. doi: 10.1159/000530589. Epub 2023 Jun 26.

    PMID: 37364559BACKGROUND
  • Duman, S., & Duruk, G. (2018). 6-12 Yaş Grubu Çocuklarda Daimi Birinci Büyük Azı Dişlerin Önemi ve Değerlendirilmesi - Derleme. Atatürk Üniversitesi Diş Hekimliği Fakültesi Dergisi, 28(4), 610-624.

    BACKGROUND
  • Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.

    PMID: 27672245BACKGROUND
  • Khan AA. The permanent first molar as an indicator for predicting caries activity. Int Dent J. 1994 Dec;44(6):623-7.

    PMID: 7851995BACKGROUND
  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PMID: 14121956BACKGROUND
  • Murrell M, Marchini L, Blanchette D, Ashida S. Intraoral Camera Use in a Dental School Clinic: Evaluations by Faculty, Students, and Patients. J Dent Educ. 2019 Nov;83(11):1339-1344. doi: 10.21815/JDE.019.140. Epub 2019 Aug 12.

    PMID: 31406005BACKGROUND
  • Nourallah AW, Splieth CH. Efficacy of occlusal plaque removal in erupting molars: a comparison of an electric toothbrush and the cross-toothbrushing technique. Caries Res. 2004 Mar-Apr;38(2):91-4. doi: 10.1159/000075931.

    PMID: 14767164BACKGROUND
  • Ozgul BM, Sakaryali D, Senirkentli GB, Tirali RE, Cehreli SB. Do really parents brush their children's teeth better? Eur J Paediatr Dent. 2019 Dec;20(4):325-329. doi: 10.23804/ejpd.2019.20.04.13.

    PMID: 31850778BACKGROUND
  • Pentapati KC, Siddiq H. Clinical applications of intraoral camera to increase patient compliance - current perspectives. Clin Cosmet Investig Dent. 2019 Aug 23;11:267-278. doi: 10.2147/CCIDE.S192847. eCollection 2019.

    PMID: 31692486BACKGROUND
  • Schiller C, Ho H, Sobue T, Katechia B, Tadinada A. Value of an Intraoral Camera in Evaluating Restorations and Plaque in a Simulated Environment: Observational Experiences of Dentists in Pediatric Contexts to Establish a Proof of Concept. Cureus. 2024 Oct 21;16(10):e72012. doi: 10.7759/cureus.72012. eCollection 2024 Oct.

    PMID: 39569297BACKGROUND
  • Schulz-Weidner N, Gruber M, Schraml EM, Wostmann B, Kramer N, Schlenz MA. Improving the Communication of Dental Findings in Pediatric Dentistry by Using Intraoral Scans as a Visual Aid: A Randomized Clinical Trial. Dent J (Basel). 2024 Jan 17;12(1):15. doi: 10.3390/dj12010015.

    PMID: 38248223BACKGROUND
  • Sharma S, Yeluri R, Jain AA, Munshi AK. Effect of toothbrush grip on plaque removal during manual toothbrushing in children. J Oral Sci. 2012;54(2):183-90. doi: 10.2334/josnusd.54.183.

    PMID: 22790411BACKGROUND
  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PMID: 14158464BACKGROUND
  • Tan WK, Chua DR. Parental use and acceptance of an accessible, commercially available intraoral camera for teledentistry in their children. Eur Arch Paediatr Dent. 2024 Apr;25(2):237-246. doi: 10.1007/s40368-024-00878-7. Epub 2024 Apr 21.

    PMID: 38643420BACKGROUND
  • Wong HM, Bridges SM, Yiu CK, McGrath CP, Au TK, Parthasarathy DS. Validation of the Hong Kong Oral Health Literacy Assessment Task for paediatric dentistry (HKOHLAT-P). Int J Paediatr Dent. 2013 Sep;23(5):366-75. doi: 10.1111/ipd.12021. Epub 2013 Jan 24.

    PMID: 23947421BACKGROUND
  • Yao Y, Luo A, Hao Y. Selective versus stepwise removal of deep carious lesions: A meta-analysis of randomized controlled trials. J Dent Sci. 2023 Jan;18(1):17-26. doi: 10.1016/j.jds.2022.07.021. Epub 2022 Aug 21.

    PMID: 36643250BACKGROUND
  • Zouashkiani, T., & Mirzakhan, T. (2006). Parental Knowledge about Presence of the First Permanent Molar and Its Effect on Health of the Tooth in 7-8 Years Old Children. J Mashad Dent Sch, 30, 225-32.

    BACKGROUND

Related Links

Study Officials

  • Melis AKYILDIZ

    Aydın Adnan Menderes University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve GÜNGÖR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
For both children and parents, the intraoral camera-assisted education or verbal instruction will be applied clearly within each group, and parents will be informed about the procedures and the study plan. To increase the scientific validity and reliability of the results, oral examinations and data collection will be done by different people. In this way, the assessors will stay blinded to the participants' group allocation during all evaluations, ensuring that the data collected are objective. The same blinding will be used for the Occlusal Plaque Index (OPI) assessment, so the examiner will evaluate plaque on first permanent molars without knowing whether the child received intraoral camera-assisted education or standard verbal instruction.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study uses a randomized, controlled, parallel-group design. Participants are randomly assigned to the intervention or control group using computer-based block randomization through Random.Org (Randomness and Integrity Services Ltd., Ireland) to ensure fair and concealed allocation. Both groups are followed during the same period. Because the intervention is educational, blinding of participants and educators is not possible; however, outcome assessors are blinded to reduce bias. This design helps us evaluate whether intraoral camera-assisted education, in addition to standard oral hygiene instruction, improves children's oral health outcomes and increases parents' oral health literacy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant prof

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 8, 2026

Study Start

February 5, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

January 9, 2026

Record last verified: 2025-09

Locations